Individualized Automatic Coaching Message for Glycemic Management and Depressive Symptom

ConditionsDiabetes Mellitus, Type 1 Continuous Glucose Measurement

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSamsung Medical Center

About this trial

This is a single-center, randomized, prospective, confirmatory study of efficacy of individualized automatic coaching message for glycemic management and depressive symptom in patients with type 1 diabetes. The study will enroll patients with type 1 diabetes who are applying continuous glucose monitoring (CGM) and receiving twice-monthly non-face-to-face management by a dedicated education nurse through the Type 1 Diabetes Home Care Project and Educational Consultation program. For 12 weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depression symptoms based on depression questionnaires, instead of non-face-to-face diabetes management. The control group will continue their current treatment and non-face-to-face diabetes management. The aim of this study is to evaluate whether the efficacy of automated, personalized coaching messages for glycemic management and depressive symptoms is non-inferior to the current non-face-to-face management approach in people with type 1 diabetes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with type 1 diabetes, age 18-75 years old

Patients who have used continuous glucose monitoring at least three months and have enrolled in Type 1 Diabetes Home Care Project and Educational Consultation program.

Patients with at least 70% of 14 days of continuous glucose monitor data within the past month

Glycated hemoglobin 7% or higher, or Glycated hemoglobin 6% or higher but less than 7% and failing to meet 1 of the continuous glucose monitor blood glucose target values: time in range (70-180 mg/L) 70% or less, or time below range (<70 mg/L) 4% or more, or time above range (>180 mg/L) 25% or more, or glucose management indicator (GMI) 7% or more, or coefficient of variation (CV%) 36% or more.

Disqualifiers

Steroid and immunosuppressant users. But it can be included if patients continuously maintain same drug dose at least three months.

Breastfeeding or pregnant patients

Patients who do not voluntarily consent to the study

Anyone deemed unsuitable by the investigator to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

individualized automatic coaching message for glycemic management and depressive symptom
Other intervention
For 12 weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on data from continuous glucose monitoring and bi-weekly personalized coaching messages for depression symptoms based on depression questionnaires, instead of non-face-to-face diabetes management.

Treatment groups

140 Participants

are divided into 2 treatment groups

Group A: Individualized automatic coaching message for glycemic management and depressive symptomsExperimental treatment 1 intervention

Group B: Current TreatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

Time In Range

Derived from continuous glucose monitoring (CGM)

Time frame

Week 12

Secondary outcomes

Diabetes treatment satisfaction

Diabetes Treatment Satisfaction Questionnaire (DTSQ); Minimum and Maximum Values: The DTSQ consists of eight items, with six items measuring satisfaction scored on a 0-6 scale (where 0 is very dissatisfied and 6 is very satisfied). The scores for these six items are summed, giving a total score range from 0 to 36. Higher Scores: Higher scores on the DTSQ indicate better satisfaction with diabetes treatment. A higher total score suggests greater satisfaction, while a lower score indicates dissatisfaction.

Time frame

Week 12

Depressive symptoms

Patient Health Questionnaire-9 (PHQ-9); Minimum and Maximum Values: The PHQ-9 consists of nine items, each scored from 0 (not at all) to 3 (nearly every day). The scores for each item are summed to give a total score, resulting in a range from 0 to 27. Higher Scores: Higher scores on the PHQ-9 indicate worse outcomes, meaning greater severity of depressive symptoms. Lower scores suggest fewer symptoms of depression or none at all. Interpretation of Scores: 0-4: Minimal or no depression; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression

Time frame

Week 12

Time In Tight Range

Derived from CGM

Time frame

Week 12

Level of Glycated Hemoglobin

Derived from blood measurement

Time frame

Week 12

Other outcomes

Level of Albuminuria

Urine creatinine-to-albumin ratio

Time frame

Week 12

Level of Glycated albumin

Glycated albumin

Time frame

Week 12

Level of total cholesterol

total cholesterol from blood measurement

Time frame

Week 12

Level of triglycerides

Level of triglycerides from blood measurement

Time frame

Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: